Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Must be conducted by a convened IRB. Must occur within 12 months of the approval date. Is limited to review of unanticipated problems.
Question
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Must be conducted by a convened IRB. Must occur within 12 months of the approval date. Is limited to review of unanticipated problems.
Solution
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB must occur within 12 months of the approval date. This review is not limited to unanticipated problems, but also includes a re-evaluation of the risk/benefit ratio, considering any new information that may have emerged during the course of the study. It is not required unless additional risks have been identified is incorrect, as continuing review is a requirement regardless of whether new risks have been identified. Lastly, it must be conducted by a convened IRB, as they are the ones who initially approved the study and are responsible for its ongoing oversight.
Similar Questions
According to federal regulations, the expedited review process may be used when the study procedures pose: Any level of risk, but all the subjects are adults. More than minimal risk, but the study replicates previously approved research. No more than minimal risk and the research activities fall within regulatory categories identified as eligible. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
What information should be provided to an IRB for review at the initiation of a study?
Study participant recruitment cannot begin until the IRB has approved the:A. Informed Consent form.B. Protocol.C. Advertisements.D. All of the above.
To document that the research participant has voluntarily agreed to participate in the study, the research participant must:A. Pass a test of comprehension.B. Meet with the institution's Institutional Review Board (IRB).C. Sign and date the Informed Consent Form.D. All of the above.
After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive:
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